Medical Device Manufacturer · US , Miami Beach , FL

Sintea Plustek, LLC - FDA 510(k) Cleared Devices

3 submissions · 3 cleared · Since 2012
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - Sintea Plustek, LLC Orthopedic ✕
3 devices
1-3 of 3
Cleared May 30, 2014
PLS (POSTERIOR LUMBAR SYSTEM)
K140787 · MNH
Orthopedic · 60d
Cleared Apr 01, 2013
SPIDER SYSTEM KOLIBRI CEMENT NEEDLE
K130402 · NDN
Orthopedic · 41d
Cleared Feb 24, 2012
SINTEA PLUSTEK ANTERIOR CERVICAL PLATE SYSTEM
K112861 · KWQ
Orthopedic · 147d
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